TerminatedPhase 4

Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH)

Stopped: no more inclusions

France10 participantsStarted 2008-01

Plain-language summary

Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.

Who can participate

Age range

4 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Prepubertal age * Prepubertal characteristics * Non GH deficient * Short children (height \< -2.5 SDS) * Born SGA (birth height \< -2 SDS) * Parental height adjusted (\< -1 DS) * No rhGH treatment before inclusion Exclusion Criteria: * ALLERY to rhGH or excipients * Small height etiologies * Cancer or cancer treatment ongoing * Drugs interference with growth * Mental impairment * Hypertrophic cardiopathy impairment * Hypertension not under controlled * Intra cranial hypertension not controlled * Diabetes and hyperglycaemia without diabetes * Dyslipidemia * Hepatitis * Kidney failure * Chromosomic aberration and/or genetic disorders (except Silver Russel Syndrome) * No social security * State of health in worst conditions after cardiac surgery, polytraumatism

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA

Timeframe: every three months during twenty seven months

Trial details

NCT IDNCT00597480

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01

View on ClinicalTrials.gov More Small for Gestational Age trials